Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter
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Product Highlights
- FDA 510K & CE Certified: Approved by FDA 510K, CE, ISO13485, FCC, and RoHS for clinical reliability.
- High Accuracy Validation: Blood oxygen accuracy <2%; ECG correlation 0.98 with P-value <0.0001.
- 20-Hour Battery Life: 3.7V 1000mAh lithium battery supports over 20 hours of continuous monitoring.
- Multi-User Compatibility: Includes probes for infants, children, and adults; suitable for various skin tones.
- Bluetooth Data Sync: Connects via Bluetooth 3.0/4.0 to record and share real-time sleep reports.
- Clinical Sleep Diagnosis: Validated for diagnosing sleep apnea syndrome with 92.59% hypoxemia accuracy.
- Compact & Portable Design: Lightweight 50g device with dimensions 68x58x20mm for easy daily use.
- Comprehensive App Support: Free BerrySmartHealth app available on Google Play and Apple Store.
Product Attributes
- Customization
- Available
- Classification
- Physiological Functions of Diagnosis and Monitoring Equipment
- Type
- Patient Monitor
- Model NO.
- BM2000A
- Certification
- CE, FDA, ISO13485
- Color
- Blue
- Suitable People
- Aged, Adult, Child
- Bluetooth
- 3.0 and 4.0
- Software
- PC, Android, Ios
- Experience
- with 10 Years Manufacturer
- R&D Department
- Excellent Engineers and Technicians
- Transport Package
- Cartoon
- Specification
- CE
- Trademark
- Berry
- Origin
- Shanghai
- HS Code
- 9018199000
- Production Capacity
- 100PCS/Day
Product Images of Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter
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Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter -
Families Care for Monitoring SpO2, Pr Healthy Situation Bluetooth Wrist Pulse Oximeter
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Product Description
BM2000A Sleep monitoring system
Suitable for sleep hypopnea syndrome monitoring
Instructions
Berry Sleep Apnea Screening Monitor has 510K, CE0123, ISO13485, FCC, RoHS and we can meet most people's measurements of blood oxygen and pulse rate. It can accurately capture pulse signals and has been validated in numerous clinical trials.
Widely Used In Daily Life
BM2000A applies to Aviation,Snorer,Child,Asthma,COPD
Major Features
1.Equipment is suitable for sleep or Apnea respiratory monitoring, especially Apnea and hypopnea monitoring.
2.Through contrast experiments with PSG, it can be used for the diagnosis of clinical sleep apnea syndrome.
3.Product is low power consumption, The 3.7V lithium battery can last for more than 20 hours.
4.The equipment has approved international CE, 510K, and other certifications.
5.Various types of sensors, which are suitable for infants and children adults and people of different ages and people of different skin colors.
6.Sleeping applet can be connected by the bluetooth. Record the data of every second actually, store and feedback the monitoring data of the whole night to the device, so as to generate the sleep report.
Operation Process
1,Download the BerrySmartHealth APP from Google Play and Apple Store.
2,Wear the equipment to keep at least 6 hours sleep monitoring.
3,Put on the device and wrap foam spO2 sensor around fingertip.
4,The collected data is transferred to the mobile phone via bluetooth.
5,Display report on phone.
6,Reports can be shared.
Technical Features
| Display SpO2, PR | Battery Type: 3.7v (1000mAh) Rechargeable Lithium Batteries |
| Pulse Rate: Measurement range: 25 - 250bpm Accuracy: ±2bpm |
SpO2: Measurement range: 35% - 100% Accuracy: ±2% (80% - 100%) ; ±3% (70% - 79%) |
| Size:68(L)x58(W)x20(D)mm | Weight: 50g |
| Working Voltage: DC 3.4v ~ DC 4.3v | Free App: "BerrySmartHealth" |
Accuracy Test
Blood Oxygen Concentration Tes Pulse Rate Test
Effective (SaO2) (ECG) [BPM]
|
Comparison: Reference Pulse Oximeter
|
|||||
|
Berry Pulse Oximeter
|
70 ~ 100
|
90 ~ 100
|
80 - < 90
|
67 - < 80
|
RESE≤3% Within the range of 70~100%
|
|
# pts
|
240
|
79
|
81
|
81
|
|
|
Error
|
-0.6
|
-1.1
|
-0.9
|
0.1
|
Pass |
|
Root mean square error
|
1.9
|
1.7
|
2.0
|
2.1
|
|
Diagnosis Of Hypoxemia OSAHS Diagnosis
Analysis Of Clinical Trial Results
|
Mean Blood Oxygen
|
||
|
Average blood oxygen calculation accuracy: 98.51%
|
||
|
Diagnosis of hypoxemia
|
||
|
Sensitivity: 89.29%
|
Specificity: 77.78%
|
Accuracy:92.59%
|
|
OSAHS Judgment Results
|
||
|
Sensitivity: 94.17%
|
Specificity: 61.21%
|
Accuracy:89.62%
|
1,Adult probe
2,Child probe
3,Neonate probe
4,Gift box
5,User manual
Physical Identity
Dimension 68(H) × 58(W) × 20(D) mm
Weight About 50g (with the batteries)
Company Information
Shanghai Berry Electronic Tech Co., Ltd. is located in Shanghai Caohejing High-tech Park, a beautiful low-carbon and environmentally friendly city. We have been devoted to the R&D, manufacturing and sales of medical electronic instruments in the field of monitoring since 2003.Our Factory
Our Bio-Medical technology has reached the domestic advanced level. Important breakthroughs have been made in non-invasive blood pressure calculation methods, blood oxygen saturation detection, and multi-parameter monitoring systems. After years of development, we have established good cooperative relations with customers worldwide, with annual sales reaching tens of millions dollars.
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASR2541914". Items marked "
" are certified.
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Company Profile
Shanghai Berry Electronic Technology Co., Ltd. is located in the international city - Shanghai Caohejing High-tech Park.
Since its establishment in September 2003, Shanghai Berry Electronic Technology Co., Ltd., as an emerging high-tech medical company, has been committed to the research and development, manufacturing and sales of medical electronic instruments in the field of monitoring, focusing on product research and development and technological innovation, Looking to the future, bringing significant benefits to those who pursue a healthy life.
Our biomedical technology has reached the domestic advanced level. Important breakthroughs have been made in non-invasive blood pressure calculation methods, blood oxygen saturation detection, and multi-parameter monitoring systems. The pulse oximeter produced by the company has won the recognition of consumers for its accurate, simple and affordable features. The products are not only sold well in China, but also exported to many countries on a large scale.
Adhering to the values of "Equality, Integrity, Innovation, Excellence", we aim to provide quality products that improve their quality of life and reduce the burden on the social healthcare system. After years of development, we have established good cooperative relationships with global customers, with annual sales reaching tens of millions of dollars.
BERRY always provides customers with high-quality, cost-effective products. Maintaining good quality is important to us.
In 2009, it obtained the production license and product registration certificate issued by Shanghai.
In 2014, we passed the EN ISO 13485 quality system certification and CE0123 certification by TÜ V SÜ D. We got the 510K for wrist and handheld pulse oximeters.
In 2015, we were accredited by ANVISA, INMETRO.
In 2016, our fingertip pulse oximeter received 510K approval.
In 2018, we received CE0123 approval for patient monitors and new watch oximeters.
In 2019, Shenzhen factory was established.
Since 2022, our business has grown rapidly and has more partners.
Shanghai Berry Electronic Technology Co., Ltd., now, we are moving forward bravely and fulfilling our promise of love.
About Our Factory & Business Background
- Address
- Suit C, 1st Floor, 7th Building, No. 1188 Lianhang Road, Minhang District, China 201112, Shanghai, China
- Terms of Payment
- LC, T/T, PayPal, Western Union, Money Gram
- International Commercial Terms(Incoterms)
- FOB, CIF, FAS, EXW
- Average Lead Time
-
Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays - Nearest Port
- shanghai, shenzhen
Our Production Capability & Technical Expertise
Our Industry Experience & Global Business Record
- Export Year
- 2013-01-01
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
FAQ
- What certifications does the device have?
- The device holds FDA 510K, CE, ISO13485, FCC, and RoHS certifications.
- How long does the battery last?
- The 3.7V 1000mAh lithium battery lasts for more than 20 hours.
- Is it suitable for children and infants?
- Yes, it includes specific probes for infants, children, and adults.
- What is the accuracy of the SpO2 measurement?
- Blood oxygen accuracy is less than 2%, meeting FDA 510K requirements.
- How is data transferred to the phone?
- Data is transferred via Bluetooth 3.0 or 4.0 to the BerrySmartHealth app.
- Can it diagnose sleep apnea?
- Yes, it is validated for clinical diagnosis of sleep apnea syndrome.
- What is the device weight and size?
- It weighs about 50g and measures 68x58x20mm.
- What payment methods are accepted?
- We accept LC, T/T, PayPal, Western Union, and Money Gram.
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